Responses to Regulated E-Cigarette Advertisements

NCT05207033 | Completed Results

• 2 other identifiers: H000225204R00DA046563-04
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (15)

• Tobacco Use at 1 Month

  Use of any tobacco products

  1 month

• Tobacco Use at 3 Months

  Use of any tobacco products

  3 months

• Tobacco Use at 6 Months

  Use of any tobacco products

  6 months

• Perceived Severity of Using E-Cigarettes at 1 Month

  Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

  1 month

• Perceived Severity of Using E-Cigarettes at 3 Months

  Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

  3 months

• Perceived Severity of Using E-Cigarettes at 6 Months

  Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

  6 months

• Motivation to Avoid E-Cigarettes at 1 Month

  Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

  1 Month

• Motivation to Avoid E-Cigarettes at 3 Months

  Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

  3 Months

• Motivation to Avoid E-Cigarettes at 6 Months

  Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

  6 Months

• Behavioral Intentions at 1 Month

  Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

  1 month

• Behavioral Intentions at 3 Months

  Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

  3 months

• Behavioral Intentions at 6 Months

  Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

  6 months

• Number of Participants With Biochemical Verification of Tobacco Use at 1 Month

  Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

  1 month

• Number of Participants With Biochemical Verification of Tobacco Use at 3 Months

  Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

  3 months

• Number of Participants With Biochemical Verification of Tobacco Use at 6 Months

  Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

  6 months

Study Arms (2)

Unregulated ad condition

ACTIVE COMPARATOR

This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.

Other: Unregulated ad condition

Regulated ad condition

EXPERIMENTAL

This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.

Other: Regulated ad condition

Interventions

Regulated ad condition OTHER

This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.

Regulated ad condition

Unregulated ad condition OTHER

This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.

Unregulated ad condition

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 26 years old,
• fluent in English (earn a score of at least 4 on the Rapid Estimate of Adult Literacy in Medicine)
• biochemically confirmed abstinence of alcohol (BrAC=.00) and combusted tobacco or marijuana exhaled carbon monoxide (eCO\<6 parts per million) at time of visit,
• reporting never trying an e-cigarette, not even a puff OR reporting tried and e-cigarette in the past but not in the past 30 days. Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire, with only those identifying anything besides "no curiosity/interest" to all three susceptibility questions as susceptible users.

You may not qualify if:

• Out of age range 18-26 years
• Use of an e-cigarette in past 30 days
• Pregnant women

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UMass Chan Medical School Stevens Lab

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Elise Stevens, Assistant Professor
• Organization: University of Massachusetts Chan Medical School

elise.stevens@umassmed.edu

(774) 455-6684

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 26, 2022
• Study Start: April 1, 2022
• Primary Completion: June 4, 2024
• Study Completion: July 1, 2024
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)